APPLICATION
ANDA209178
TYPE
ANDA
ORIGINAL APPROVAL
2018-02-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
IBUPROFENPrescription
IBUPROFEN 100MG/5ML · SUSPENSION · ORAL
Approval history
2024-11-21Labeling · Supplement 13 · standardAP
2021-04-28Labeling · Supplement 7 · standardAP
2021-04-13Labeling · Supplement 6 · standardAP
2019-07-22Labeling · Supplement 4 · standardAP
2018-05-18Manufacturing (CMC) · Supplement 2 · unknownAP
2018-02-16UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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